Phase 4
N=50
Lower Third Molar Removal With 2% and 4% Articaine
Impacted Third Molar Tooth · Adverse Reaction to Other Local Anesthetics
Bottom Line
View on ClinicalTrials.gov: NCT02457325 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Onset of Anesthetic — 1.5; 1.5 minutes — p=0.192
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Surgery with 2%Articaine first, then Surgery with 4% Articaine (Drug); Surgery with 4%Articaine first, then Surgery with 2% Articaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Onset of Anesthetic |
1.5; 1.5 | 0.192 |
| PRIMARY Quality of Anesthesia |
1.8; 1.8 | 0.457 |
| PRIMARY Intraoperative Bleeding |
1.1; 1.1 | 0.158 |
| PRIMARY Blood Pressure |
119; 123 | 0.953 |
| PRIMARY Heart Rate |
73; 73 | 0.693 |
| PRIMARY Oxygen Saturation |
99; 99 | 0.158 |
| SECONDARY Duration of Post-operative Analgesia |
133; 125 | 0.192 |
| SECONDARY Postoperative Mouth Opening |
36; 35 | 0.512 |
| SECONDARY Wound Healing of the Operated Area |
1.2; 1.4 | 0.115 |
| SECONDARY Evaluation of Post-surgical Pain |
26; 26 | 0.730 |
| SECONDARY Postoperative Anesthesia |
187; 215 | 0.835 |
Summary
The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.
Eligibility Criteria
Inclusion Criteria
- Need of lower third molar surgeries in similar positions
Exclusion Criteria
- Presence of systemic diseases;
- Presence of local inflammation and/or infection;
- Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
- Cardiovascular and kidney diseases;
- Asthma and allergy to aspirin, piroxicam or any other non-steroidal antiinflammatory drug;
- Regular use of any non-steroidal antiinflammatory drug, pregnancy or breast feeding.
Data sourced from ClinicalTrials.gov (NCT02457325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.